Novartis gains U.S. approval for delayed MS drug

ZURICH (Reuters) – Novartis’s Sandoz division has won U.S. approval for a larger dosage of its Glatopa drug for multiple sclerosis (MS) patients, ending a costly delay that allowed rival generics makers to beat it to market.

The U.S. Food and Drug Administration (FDA) approved a 40 milligrams per milliliter injection of the Novartis copy of Copaxone, Teva’s blockbuster medicine, Sandoz said in a statement on Tuesday.

Sandoz began selling a 20 mg/ml Glatopa dosage to U.S. patients with relapsing MS in 2015 but missed out on millions of dollars in sales after the double-dosage version was pushed back last year after contamination problems at the Pfizer fill-and-finish plant being used by Sandoz.

The FDA approval, which Novartis had expected in the second half of this year, could help to compensate for the recent FDA delay of a Sandoz version of GlaxoSmithKline’s asthma and COPD drug Advair, analysts said. The drug’s launch is now unlikely before 2019.

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The Pfizer plant problems scuttled plans to have the larger Glatopa dosage on sale first in 2017, allowing Mylan to muscle in on lucrative market share with its quicker-to-market Copaxone copy.

Pfizer said last month that the FDA had upgraded the compliance status of its Kansas facility, clearing the way for the Novartis-Momenta medicine.

Overall, Sandoz has been a drag on Novartis results in recent months, with its pills portfolio particularly sensitive to U.S. price pressure. The division’s sales fell 1 percent last year to $10.1 billion and Novartis expects sales to be dented by stagnating or declining revenue at Sandoz in 2018.

Novartis is reviewing Sandoz’s U.S. pills business for a potential disposal and aims to focus on more complex injectible drugs in its generics portfolio, such as Glatopa, as well as biosimilars.